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Health Canada bottleneck frustrates Delhi manufacturer

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Clearstream Filters of Delhi stepped up when Premier Doug Ford issued an urgent call this spring for personal protective equipment.

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The Trudeau government had just shipped Canada’s inventory of PPE to China in an effort to contain the COVID-19 pandemic and Ontario was impacted by the resulting nation-wide shortage.

Clearstream has made the transition to PPE, in the process tripling its shifts and doubling its workforce. But the company – which is currently focused on water-proof masks and sanitary gowns – feels it could do much more if it had certification to supply hospitals, clinics and other medical settings.

“The government is our biggest hang-up at the moment,” said CEO Tony Lane. “But we can’t get permission from Health Canada. They keep telling us ‘It’s under review; It’s under review.’ Well, how many times can they review it?

“If our name were General Motors, I’m sure the response would be different.”

Prior to the pandemic, Clearstream’s focus was the design and production of industrial filters.

The shift to PPE for non-medical customers such as grocery stores and other private businesses has allowed the company to expand. However, Clearstream feels it could do much more if someone from Health Canada would examine, test and certify their new product line.

“We’ve done everything the government has asked us to do,” said general manager Cindy Ketchabaw. “We didn’t lay off anyone and we’ve donated to the community.

“I feel Clearstream has gone over and above what the government has asked us to do. We’d like a little help back. It’s been very frustrating. We do have the property and ability to expand if we have to. If someone could give us a hand we could make this operation bigger. That would be huge for Delhi. ”

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Clearstream has involved as many elected officials at all levels that it can, but to no effect. A call to the Health Canada media line was not returned before deadline.

Part of the problem could be that COVID-19 struck in the middle of a Health Canada regulatory review for medical-grade devices. Announced in March 2018, the “project” is designed to rationalize and streamline the certification process.

“We expect a formal meeting process to result in earlier interactions with device manufacturers,” the Health Canada website says. “A formal, pre-clinical meeting process will allow manufacturers to discuss regulatory evidence requirements and investigational testing protocol design with Health Canada early in the device development process.

“Our aim is to develop and implement processes that facilitate effective communication between medical device manufacturers and Health Canada in order to improve the quality of submissions and provide more timely regulatory decisions. This will result in medical devices reaching Canadians faster. We expect that all parts of the project will be fully in place by June 2020.”

Lane wasn’t aware of this process until told of it on Aug. 11. He found it interesting because he knows of manufacturers who have pivoted to PPE who were fast-tracked for approval in recent months.

Haldimand-Norfolk MP Diane Finley has made inquiries in Ottawa on behalf of Clearstream.

“We’ve been in touch with the Minister of Health’s office to check on the status of Clearstream Filters’ application,” Finley said in an email. “But, the fact remains the Liberal government should be getting rid of red tape that does nothing to ensure safety so Canadian companies are the ones filling PPE shortages instead of foreign producers.”

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